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D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab (D-TECT)

21 de julho de 2026 atualizado por: Universitätsklinikum Hamburg-Eppendorf

D-TECT: Prospective Multicenter Evaluation of Pretreatment D-dimer Levels as a Predictor of Disease Control in Advanced Cutaneous Squamous Cell Carcinoma Treated With Cemiplimab

D-TECT is a prospective, multicenter, non-interventional observational study investigating whether pretreatment D-dimer levels predict disease control in patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care.

D-dimers are routinely available laboratory markers related to activation of the coagulation system. Previous single-center data suggest that elevated pretreatment D-dimer levels may be associated with poorer disease control under cemiplimab. In D-TECT, a single pretreatment D-dimer value and prospectively collected routine clinical follow-up data will be analyzed to validate this association in a multicenter real-world setting. No study-specific treatment decisions, imaging procedures, or additional blood draws are mandated by the study.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Cutaneous squamous cell carcinoma (cSCC) is one of the most common skin cancers. While most cases can be treated with curative local therapy, a subgroup of patients develops locally advanced or metastatic disease requiring systemic treatment. Cemiplimab, a PD-1 inhibitor, is an established systemic treatment option for advanced cSCC. However, validated routine biomarkers predicting disease control under cemiplimab are lacking.

D-dimers are fibrin degradation products and sensitive markers of coagulation activation. In a prior single-center retrospective analysis, elevated pretreatment D-dimer levels were associated with lower disease control, lower objective response, and shorter progression-free survival in patients with advanced cSCC treated with cemiplimab. D-TECT is designed to prospectively validate this observation in a multicenter real-world cohort.

Eligible patients are adults with histologically confirmed locally advanced or metastatic cSCC for whom cemiplimab treatment is planned as part of routine clinical care. A D-dimer measurement is documented within 7 days before the first cemiplimab dose up to the day of first administration before infusion. Subsequent clinical data, including tumor response, progression, survival, treatment discontinuation, and thromboembolic events, are collected from routine medical records during follow-up.

The primary endpoint is disease control within the first 6 months after initiation of cemiplimab. The primary confirmatory analysis compares disease control between patients with high versus low pretreatment D-dimer values using the prespecified cutoff of 0.91 mg/L FEU derived from the prior single-center study. If the primary analysis is statistically significant, the same primary endpoint will be tested hierarchically using the local laboratory-defined upper limit of normal. Additional analyses include objective response rate, progression-free survival, overall survival, thromboembolic events, diagnostic performance measures of the predefined cutoffs, sensitivity analyses, and exploratory analyses addressing inter-site assay heterogeneity.

Tipo de estudo

Observacional

Inscrição (Estimado)

116

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Glenn Geidel, MD, MSc
  • Número de telefone: +49 (0)40 7410 70743
  • E-mail: g.geidel@uke.de

Locais de estudo

  • Alemanha
      • Bielefeld, Alemanha, 33647
        • University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
        • Contato:
        • Investigador principal:
          • Selma Ugurel, MD
      • Bremerhaven, Alemanha, 27574
        • Klinikum Bremerhaven Reinkenheide
        • Contato:
        • Investigador principal:
          • Michael M. Sachse, MD
      • Buxtehude, Alemanha, 21614
        • Elbe Klinikum Buxtehude
        • Contato:
        • Investigador principal:
          • Kai-Martin Thoms, MD
      • Erlangen, Alemanha, 91054
        • University Medical Center Erlangen
        • Contato:
        • Investigador principal:
          • Markus V. Heppt, MD, PhD, MHBA
      • Göttingen, Alemanha, 37075
        • University Medical Center Göttingen
        • Contato:
        • Investigador principal:
          • Katharina Amschler, MD
      • Hamburg, Alemanha, 20246
        • University Medical Center Hamburg-Eppendorf
        • Contato:
          • Glenn Geidel, MD, MSc
          • Número de telefone: +49 (0)40 741070743
          • E-mail: g.geidel@uke.de
        • Investigador principal:
          • Glenn Geidel, MD, MSc
      • Hanover, Alemanha, 30625
        • Hannover Medical School
        • Contato:
        • Investigador principal:
          • Imke von Wasielewski, MD
      • Kiel, Alemanha, 24105
        • University Medical Center Schleswig-Holstein, Campus Kiel
        • Investigador principal:
          • Katharina Kähler, MD
        • Contato:
      • Lübeck, Alemanha, 23538
        • University Medical Center Schleswig-Holstein, Campus Lübeck
        • Contato:
        • Investigador principal:
          • Dagmar von Bubnoff, MD
      • Mainz, Alemanha, 55131
        • University Medical Center Mainz
        • Contato:
        • Investigador principal:
          • Henner Stege, MD
      • Mannheim, Alemanha, 68167
        • University Medical Center Mannheim
        • Investigador principal:
          • Jochen Utikal, MD
        • Contato:
      • Minden, Alemanha, 32429
      • Rostock, Alemanha, 18057
        • University Medical Center Rostock
        • Contato:
        • Investigador principal:
          • Markus Thieme, MD
      • Tübingen, Alemanha, 72076
        • University Medical Center Tübingen
        • Investigador principal:
          • Ulrike Leiter, MD
        • Contato:
  • Áustria
      • Salzburg, Áustria, 5020
        • University Medical Center Salzburg
        • Contato:
          • Matthias Brandlmaier, MD, PhD, MSc
          • Número de telefone: +43 (0) 57255 24601
          • E-mail: m.brandlmaier@salk.at
        • Investigador principal:
          • Matthias Brandlmaier, MD, PhD, MSc

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult patients with histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma for whom systemic treatment with cemiplimab is planned as part of routine clinical care at participating oncology/dermato-oncology centers.

Descrição

Inclusion Criteria:

  • Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
  • Planned initiation of systemic treatment with cemiplimab as part of routine clinical care
  • Pretreatment D-dimer measurement performed within 7 days before initiation of cemiplimab treatment up to the day of first administration before infusion
  • Age 18 years or older at the time of consent
  • ECOG performance status 0 to 2
  • Written informed consent for study participation and pseudonymized collection and analysis of clinical and laboratory data

Exclusion Criteria:

  • Prior treatment with immune checkpoint inhibitors in curative or palliative intent for cutaneous squamous cell carcinoma
  • Concurrent second malignancy requiring systemic treatment, such as chemotherapy, immunotherapy, or targeted therapy
  • Clinically unstable comorbidity, including NYHA class III-IV heart failure or active systemic infection
  • Acute symptomatic thrombosis or pulmonary embolism within 4 weeks before the pretreatment D-dimer measurement
  • Incidental asymptomatic thromboembolic events detected during clinical diagnostic work-up or following an elevated D-dimer result are not exclusion criteria and will be documented
  • Physician-estimated life expectancy of less than 3 months or severe non-tumor-related comorbidity likely to preclude assessment of the clinical course within the first 6 months
  • Lack of capacity to consent or legal guardianship without valid legal representation

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
High pretreatment D-dimer
Patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care and a pretreatment D-dimer level above the prespecified cutoff of 0.91 mg/L FEU.
Outro: Pretreatment D-dimer status
Pretreatment D-dimer status is defined using a single D-dimer measurement obtained in routine clinical laboratory testing within 7 days before the first cemiplimab dose up to the day of first administration before infusion. D-dimer status is not used to assign treatment and does not mandate any study-specific diagnostic or therapeutic intervention.
Low pretreatment D-dimer
Patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care and a pretreatment D-dimer level at or below the prespecified cutoff of 0.91 mg/L FEU.
Outro: Pretreatment D-dimer status
Pretreatment D-dimer status is defined using a single D-dimer measurement obtained in routine clinical laboratory testing within 7 days before the first cemiplimab dose up to the day of first administration before infusion. D-dimer status is not used to assign treatment and does not mandate any study-specific diagnostic or therapeutic intervention.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
Prazo: From start of cemiplimab treatment through 6 months
Disease control rate is defined as the proportion of participants with complete response, partial response, or stable disease according to clinical and/or radiological assessment in routine care within the first 6 months after initiation of cemiplimab. Participants with documented progression, death, or treatment discontinuation due to clinical progression within the first 6 months are considered not to have disease control. Participants without documented progression or death but without evaluable clinical or radiological follow-up assessment within the first 6 months are considered not evaluable for the primary analysis. The primary confirmatory analysis compares disease control between participants with high versus low pretreatment D-dimer levels using the prespecified cutoff of 0.91 mg/L FEU. If statistically significant, the same primary endpoint will be tested hierarchically using the local laboratory-defined upper limit of normal.
From start of cemiplimab treatment through 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate
Prazo: From start of cemiplimab treatment through 24 months
Objective response rate is defined as the proportion of participants with complete response or partial response according to clinical and/or radiological assessment in routine care during follow-up.
From start of cemiplimab treatment through 24 months
Progression-Free Survival
Prazo: From start of cemiplimab treatment through 24 months
Progression-free survival is defined as the time from initiation of cemiplimab treatment to the first documented disease progression or death from any cause, whichever occurs first.
From start of cemiplimab treatment through 24 months
Overall Survival
Prazo: From start of cemiplimab treatment through 24 months
Overall survival is defined as the time from initiation of cemiplimab treatment to death from any cause.
From start of cemiplimab treatment through 24 months
Thromboembolic Events During Follow-up
Prazo: From start of cemiplimab treatment through 24 months
Incidence of venous or arterial thromboembolic events documented during follow-up and evaluated in relation to pretreatment D-dimer levels.
From start of cemiplimab treatment through 24 months
Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
Prazo: From start of cemiplimab treatment through 6 months
Sensitivity, specificity, positive predictive value, and negative predictive value of the prespecified D-dimer cutoff of 0.91 mg/L FEU and of the local laboratory-defined upper limit of normal for disease control within the first 6 months after initiation of cemiplimab.
From start of cemiplimab treatment through 6 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
Prazo: From start of cemiplimab treatment through 24 months
Exploratory competing-risk analysis of the cumulative incidence of documented disease progression, treating death without prior documented progression as a competing event. Deaths without prior documented progression will additionally be described by cause of death where available from the medical record.
From start of cemiplimab treatment through 24 months
Association of Pretreatment D-dimer Levels With Clinical Outcomes in Multivariable Models
Prazo: From start of cemiplimab treatment through 24 months
Exploratory multivariable models evaluating the association between pretreatment D-dimer levels and clinical outcomes while accounting for predefined clinical covariates such as performance status, lactate dehydrogenase, comorbidities, and anticoagulation.
From start of cemiplimab treatment through 24 months
Exploratory Analysis of Assay-Related Heterogeneity in D-dimer Measurements
Prazo: Baseline through 24 months
Exploratory evaluation of inter-site heterogeneity in D-dimer assays, measurement units, and local reference ranges. Analyses may include ULN-normalized D-dimer values defined as the quotient of the measured value and the local upper limit of normal.
Baseline through 24 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universitätsklinikum Hamburg-Eppendorf

Investigadores

  • Investigador principal: Glenn Geidel, MD, MSc, Universitätsklinikum Hamburg-Eppendorf

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

31 de julho de 2028

Conclusão do estudo (Estimado)

31 de março de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

28 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de junho de 2026

Primeira postagem (Real)

6 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D-TECT
  • DRKS00040746 (Identificador de registro: German Clinical Trials Register)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

No individual participant data will be shared. Study data will be analyzed in pseudonymized form by the coordinating study center. Any further use of study data beyond the present research question would require additional ethical and data protection review and, where applicable, additional consent.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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